Decreasing Postoperative Complications by Goal-Directed Fluid Therapy During Esophageal Resection

University Hospital, Linkoeping

Status and phase: Completed; Phase 4

Conditions: Esophageal Cancer

Treatments: Other: fluid optimisation

Study type: Interventional

Funder types: Other

Identifiers

NCT01416077

USANOP001

Details and patient eligibility

About

Surgery for cancer of the esophagus is associated with a high risk of postoperative complications. It has been shown that the risk of postoperative complications can be decreased by optimising the amount and type of infusion fluids given during surgery, steered by measurement of cardiac stroke volume, mostly done with a device called esophageal Doppler. This device can however not be used during this type of surgery. This study wants to test the hypothesis that postoperative complications in patients operated for esophageal cancer can be partially prevented by using a goal directed strategy for the administration of fluids and drugs influencing the heart and vessels, based on measurement of stroke volume by pulse wave analysis (FloTrac).

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for transthoracic esophageal resection because of malignancy, without colonic interposition who leave informed consent

Exclusion criteria

• ASA 4 or 5
• Atrial Fibrillation
• Significant Aortic or Mitral Valve Insufficiency
• Preoperative planned extensive monitoring beyond CVP, arterial blood pressure, diuresis, ECG and other standard monitors

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

standard treatment

No Intervention group

Description:

Fluid and inotropic drugs are given based on conventional parameters such as blood pressure and heart rate as judged by the individual anesthesiologists judgement.

goal-directed fluid treatment

Active Comparator group

Description:

Stroke Volume and Cardiac Index are measured with the Flotrac/Vigileo system and circulation is optimised

Treatment:

Other: fluid optimisation